Ondibta
Insulin glargine biosimilar developed by Gan & Lee Pharmaceuticals. Reference product Lantus.
About Ondibta
Ondibta is an insulin glargine developed by Gan & Lee of China and sold in Europe by Sandoz, approved in January 2026. Gan & Lee is China's largest insulin maker and this was its first European approval, with an insulin aspart and an insulin lispro following the same year.
Status by market
United States
Not listed by FDA.
European Union · Ondibta
European Medicines Agency and European CommissionApprovedUnited Kingdom
Not listed by MHRA.
Japan
Not listed by PMDA.
Canada
Not listed by HC.
India
Not listed by CDSCO.
United Arab Emirates
Not listed by EDE.
Other developers in the same markets
Where Ondibta holds an approval, these are the other insulin glargine biosimilars approved in that market.
| Market | Rivals | Developers (product) |
|---|---|---|
| EMA | 2 | Biocon Biologics (Semglee), Eli Lilly (Rezvoglar / Abasaglar) |
Same developer, other molecules
Other biosimilars in the Atlas developed by Gan & Lee Pharmaceuticals: Bysumlog, Dazparda.
Chronology
- EMAJan 2026Authorised by the European Commission
Sources
S017EMA, medicines data table (medicines-output-medicines-report_en.xlsx) Primary (regulator)
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